TAG:
laboratory industry
Truvian Sciences Raises $105M for Near-Patient Lab Test System
By Robert Michel | From the Volume XXVIII, No. 4 – March 22, 2021 Issue
DESPITE THE PANDEMIC, investors continue to support emerging in vitro diagnostics (IVD) companies. This is particularly true of start-up companies that want to develop clinical lab testing systems that can be used at the point of care, that require small amounts of blood, and that deliver accu…
Pathologist’s Prison Term Is a Warning for AP Groups
By Robert Michel | From the Volume XXVIII No. 3 – March 1, 2021 Issue
CEO SUMMARY: In January, a former VA pathologist was sentenced to 20 years in federal prison following his conviction on charges of involuntary manslaughter and mail fraud. The facts in this case show why leaders of clinical labs and pathology groups need to be aware of individuals …
SARS-CoV-2 Variant Sequencing Creates New Opportunities for Labs
By Robert Michel | From the Volume XXVIII, No. 2 – February 8, 2021 Issue
This is an excerpt of a 2,964-word article in the February 8, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Variants of the COVID-19 virus are appearing across the world. Recent data show the same variants wil…
Variant Sequencing of SARS-CoV-2 Creates Opportunities for Labs
By Robert Michel | From the Volume XXVIII, No. 2 – February 8, 2021 Issue
CEO SUMMARY: Variants of the COVID-19 virus are appearing across the world. Recent data show the same variants will infect people in several different countries. Here in the United States, interest is growing in having clinical laboratories sequence specimens from patients who test pos…
Top 10 2020 Lab Stories Are about More than Just COVID-19
By Robert Michel | From the Volume XXVII, No. 18 – December 28, 2020 Issue
This is an excerpt of a 3,689-word article in the December 28, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: There are several surprises in The Dark R…
2020’s Top 10 Lab Stories Are Without Precedent!
By Robert Michel | From the Volume XXVII, No. 18 – December 28, 2020 Issue
CEO SUMMARY: There are several surprises in The Dark Report’s list of the Top 10 Lab Stories for 2020. Despite the SARS-CoV-2 pandemic dominating every aspect of clinical care, social…
OIG Says Medicare Spending On Testing Increased in 2019
By Robert Michel | From the Volume XXVII, No. 18 – December 28, 2020 Issue
CEO SUMMARY: Newly-released data indicates that Medicare officials are falling far short of their goal to decrease the total amount of money spent annually on Part B clinical laboratory tests. That is one finding by the federal Office of the Inspector General in its report of Medica…
Why Labs Operate in a ‘Duality’ during Pandemic
By R. Lewis Dark | From the Volume XXVII, No. 17 – December 7, 2020 Issue
HAS IT OCCURRED TO MANY OF YOU THAT YOUR CLINICAL LABORATORIES today must operate in what I will describe as an operational “duality”? On one side, your lab must deal with COVID-19 testing. This is true whether your lab performs molecular SARS-CoV-2…
COVID-19 or Not, Lab Market Enters ‘Twilight Zone’
By R. Lewis Dark | From the Volume XXVII, No. 16 – November 16, 2020 Issue
Our healthcare system is in a most remarkable state. Even as all providers—including clinical laboratories and anatomic pathology groups—continue to devote considerable resources to meeting the urgent need for SARS-CoV-2 testing, health insurers and regulators continue to issue new requirements g…
Palmetto GBA Tells Consultant to Take Down Test Price Data
By Robert Michel | From the Volume XXVII, No. 16 – November 16, 2020 Issue
CEO SUMMARY: Lawyers for Medicare contractor Palmetto GBA sent a cease and desist letter in September to a respected lab consultant, telling him to delete from his health policy blog a document containing Medicare genetic test price and coding data. In the letter, Quinn was directed…
CURRENT ISSUE

Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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